Advanced Solid TumorPhase 1/2NCT05902988
A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer
A Phase 1/2 study testing VLS-1488 in people with Advanced Solid Tumor and High Grade Serous Adenocarcinoma of Ovary, run by Volastra Therapeutics, Inc. at 14 sites in United States.
Trial summary
This is a first-in-human phase I/II study to examine the safety, tolerability and preliminary efficacy of VLS-1488 in subjects with advanced cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, High Grade Serous Adenocarcinoma of Ovary, Squamous Non-small-cell Lung Cancer
- What is being tested?
- VLS-1488
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 14 sitesUnited States
- Study dates
- 18 Oct 2023to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Parts: Age ≥ 18 years, ECOG Performance Status ≤ 1, at least 1 site of measurable disease evaluable by CT scan or MRI per RECIST 1.1, able to take oral medication without alteration
- Dose Escalation: No available therapeutic options to provide clinically meaningful benefits in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non -Small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction, Bladder (transitional cell), Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), Ovarian Carcinosarcoma, CN-high Endometrial/Uterine
- Dose Expansion: Must have been previously treated with several lines of standard of care treatment specified in the protocol in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non-Small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), CN-high Endometrial/Uterine
Who cannot join
- MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype
- Previously received KIF18A inhibitor
- Current CNS metastases or leptomeningeal disease
- Cardiac parameters: MI or stroke ≤ 1 year, unstable angina/PE/DVT/CABG ≤ 6 months, NYHA Class ≥ II, LVEF < 50%
- Inability to comply with concomitant medication restrictions with respect to strong inhibitors and inducers of CYP3A, and clinical inhibitors of MDR1 (P-gp) and BCRP
- Any clinically significant ascites or pleural effusions at time of enrollment, or any therapeutic paracentesis or thoracentesis within 28 days of planned first dose of study drug
- Bowel obstruction or GI perforation within 6 months of planned first dose of study drug
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 13 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Cancer AnswerLine, 800-865-1125, CancerAnswerLine@med.umich.edu
- Recruiting
University of Colorado Cancer Center
Aurora, Colorado, 80045
Yasmin Yazdani Farsad, 303-724-9403, YASMIN.YAZDANIFARSAD@CUANSCHUTZ.EDU
- Recruiting
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21224
Matthew Bark, 443-927-8743, Mbark1@jhmi.edu
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Abby Reed, RN, 513-585-1140, abby.reed@thechristhospital.com
- Recruiting
Kellogg Cancer Center
Evanston, Illinois, 60201
Michele Britto, (847) 570-2109, mbritto@northshore.org
- Active, not recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
M.D. Anderson Cancer Center
Houston, Texas, 77030
Ecaterina Dumbrava, MD, 713-792-3934, eeileana@mdanderson.org
- Recruiting
Community Health Network
Indianapolis, Indiana, 46256
Megan Haas, mhaas2@ecommunity.com
- Recruiting
University of Southern California
Los Angeles, California, 90033
Xiomara Menendez, RN, Xiomara.Menendez@med.usc.edu
Lorraine Martinez, MD, Lorraine.Martinez@med.usc.edu
- Recruiting
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Clinical Trials Office, 414-805-8900, cccto@mcw.edu
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06511
Ingrid Palma, 203-833-1034, ingrid.palma@yale.edu
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Claire Friedman, MD, 646-888-4593, friedmac@mskcc.org
- Recruiting
Hoag Memorial Hospital
Newport Beach, California, 92663
Patrice Jones, 9497645501, patrice.jones@hoag.org
- Recruiting
Women & Infants Hospital
Providence, Rhode Island, 02905
Emma Locke, 401-430-8181, oncologyresearch@wihri.org
About this study
Official title: A Phase I/II Study of VLS-1488 (an Oral KIF18A Inhibitor) in Subjects With Advanced Cancer
This is a first-in-human phase I/II study to examine the safety, tolerability and preliminary efficacy of VLS-1488 in subjects with advanced cancers.
Read the detailed description
This a first-in-human phase I/II study designed to assess the safety, tolerability and preliminary efficacy of VLS-1488 monotherapy and consists of two parts: Dose Escalation and Dose Expansion.
Dose Escalation will examine the safety and tolerability of VLS-1488 in different solid tumor types at various dose levels through a series of Dose Escalation and Backfill Cohorts to identify the Maximum Tolerated Dose (MTD) and to select dose levels for Dose Expansion. The criteria for dose (de-)escalation will be based on a Bayesian Optimal Interval (BOIN) design.
Dose Expansion will examine the safety, tolerability, Drug Drug Interaction (DDI) risk, Food Effect (FE) and preliminary efficacy of VLS-1488 in different tumor types and/or dose levels of interest through various expansion cohorts.
VLS-1488 will be given orally in 28-day cycles. Dosing will be continued until disease progression, unacceptable toxicity, withdrawal of consent, or other stopping criteria are met.
- Conditions
- Advanced Solid Tumor, High Grade Serous Adenocarcinoma of Ovary, Squamous Non-small-cell Lung Cancer, Triple Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma, Ovarian Carcinosarcoma
- Being tested
- VLS-1488
- Keywords
- KIF18A Inhibitor, HGSOC, TNBC, HNSCC, sqNSCLC
- Medical subject headings
- Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck, Endometrial Neoplasms, Chromosomal Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLS-1488Drug
VLS-1488 tablets will be given orally.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation: Dose Escalation Cohorts | Experimental | Subjects will be enrolled at various doses and/or schedules of VLS-1488. These Dose Escalation Cohorts will be utilized to identify the MTD and to select dose levels for Dose Expansion. Receives: Drug: VLS-1488 |
| Dose Escalation: Backfill Cohorts | Experimental | Additional subjects may be enrolled at any dose level that does not meet de-escalation or elimination rules per the BOIN design. These Backfill Cohorts will be utilized to build additional data to support selection of doses and/or tumor types for further study in Dose Expansion. Receives: Drug: VLS-1488 |
| Dose Expansion: Exploration Cohorts | Experimental | Subjects with a selected single tumor type will be randomized 1:1 into Exploration Cohorts at two or more dose levels of interest. A subset of subjects will have additional assessments to examine the potential for VLS-1488 to interact with other drugs and the effect of food on VLS-1488 absorption. Receives: Drug: VLS-1488 |
| Dose Expansion: Development Cohorts | Experimental | Subjects with other tumor types will be enrolled at a single dose level of interest. These Development Cohorts will be utilized to examine the preliminary efficacy of VLS-1488 in various tumor types. Receives: Drug: VLS-1488 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects
Measured: Up to 12 months
Dose Escalation: Determination of the MTD of VLS-1488
Measured: Up to 12 months
Dose Escalation: Frequency of Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Measured: Up to 12 months
Dose Escalation: Frequency of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0
Measured: Up to 12 months
Dose Escalation: Frequency of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0
Measured: Up to 12 months
Dose Escalation: Frequency of Dose Interruptions and Permanent Treatment Discontinuations
Measured: Up to 12 months
Dose Expansion: Frequency of Trigger Events (TEs)
Measured: Up to 18 months
Dose Expansion: Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Up to 18 months
Secondary outcomes (19)
Dose Escalation: ORR as assessed by RECIST version 1.1
Measured: Up to 12 months
Dose Expansion: Frequency of SAEs graded according to NCI-CTCAE version 5.0
Measured: Up to 18 months
Dose Expansion: Frequency of Treatment-related AEs graded according to NCI-CTCAE version 5.0
Measured: Up to 18 months
Dose Expansion: Frequency of TEAEs graded according to NCI-CTCAE version 5.0
Measured: Up to 18 months
Dose Expansion: Frequency of Dose Interruptions and Permanent Treatment Discontinuations
Measured: Up to 18 months
Dose Expansion: Area Under the Plasma Concentration-Time Curve (AUC) of Midazolam and its metabolite 1'-hydroxymidazolam
Measured: Up to 18 months
Dose Expansion: Maximum Plasma Concentration (Cmax) of Midazolam and its metabolite 1'-hydroxymidazolam
Measured: Up to 18 months
Dose Expansion: Evaluation of CA-125 response by Gynecologic Cancer InterGroup (GCIG) criteria (High Grade Serous Ovarian Cancer only)
Measured: Up to 18 months
Dose Escalation & Dose Expansion: Duration of Response (DOR) as assessed by RECIST version 1.1
Measured: Up to 32 months
Dose Escalation & Dose Expansion: Disease Control Rate (DCR) as assessed by RECIST version 1.1
Measured: Up to 32 months
Dose Escalation & Dose Expansion: Progression Free Survival (PFS) as assessed by RECIST version 1.1
Measured: Up to 32 months
Dose Escalation & Dose Expansion: Cmax of VLS-1488
Measured: Up to 32 months
Dose Escalation & Dose Expansion: AUC of VLS-1488
Measured: Up to 32 months
Dose Escalation & Dose Expansion: Trough Concentration (Ctrough) of VLS-1488
Measured: Up to 32 months
Dose Escalation & Dose Expansion: Time to Maximum Plasma Concentration (Tmax) of VLS-1488
Measured: Up to 32 months
Dose Escalation & Dose Expansion: Ratio of Total Cholesterol to 4β-hydroxycholesterol in plasma
Measured: Up to 32 months
Dose Escalation & Dose Expansion: Increase in the number of Phospho-Histone 3 positive tumor cells
Measured: Up to 32 months
Dose Escalation & Dose Expansion: Frequency of Micronucleated Reticulocytes in blood
Measured: Up to 32 months
Dose Escalation & Dose Expansion: Increase in Micronuclei in Circulating Tumor Cells
Measured: Up to 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start18 Oct 2023
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Volastra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902988
- Sponsor's protocol ID
- VLS-1488-2201
- Status last verified
- Oct 2025
- First submitted
- 31 May 2023
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of VLS-1488 (an Oral KIF18A Inhibitor) in Subjects With Advanced Cancer
- ClinicalTrials.gov ID
- NCT05902988
- Acronym / sponsor ID
- VLS-1488-2201
- Conditions
- Advanced Solid Tumor, High Grade Serous Adenocarcinoma of Ovary, Squamous Non-small-cell Lung Cancer, Triple Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma, Ovarian Carcinosarcoma
- Keywords
- KIF18A Inhibitor, HGSOC, TNBC, HNSCC, sqNSCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Volastra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human phase I/II study to examine the safety, tolerability and preliminary efficacy of VLS-1488 in subjects with advanced cancers.
Detailed description
This a first-in-human phase I/II study designed to assess the safety, tolerability and preliminary efficacy of VLS-1488 monotherapy and consists of two parts: Dose Escalation and Dose Expansion.
Dose Escalation will examine the safety and tolerability of VLS-1488 in different solid tumor types at various dose levels through a series of Dose Escalation and Backfill Cohorts to identify the Maximum Tolerated Dose (MTD) and to select dose levels for Dose Expansion. The criteria for dose (de-)escalation will be based on a Bayesian Optimal Interval (BOIN) design.
Dose Expansion will examine the safety, tolerability, Drug Drug Interaction (DDI) risk, Food Effect (FE) and preliminary efficacy of VLS-1488 in different tumor types and/or dose levels of interest through various expansion cohorts.
VLS-1488 will be given orally in 28-day cycles. Dosing will be continued until disease progression, unacceptable toxicity, withdrawal of consent, or other stopping criteria are met.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation: Dose Escalation Cohorts | Experimental | Drug: VLS-1488Subjects will be enrolled at various doses and/or schedules of VLS-1488. These Dose Escalation Cohorts will be utilized to identify the MTD and to select dose levels for Dose Expansion. |
| Dose Escalation: Backfill Cohorts | Experimental | Drug: VLS-1488Additional subjects may be enrolled at any dose level that does not meet de-escalation or elimination rules per the BOIN design. These Backfill Cohorts will be utilized to build additional data to support selection of doses and/or tumor types for further study in Dose Expansion. |
| Dose Expansion: Exploration Cohorts | Experimental | Drug: VLS-1488Subjects with a selected single tumor type will be randomized 1:1 into Exploration Cohorts at two or more dose levels of interest. A subset of subjects will have additional assessments to examine the potential for VLS-1488 to interact with other drugs and the effect of food on VLS-1488 absorption. |
| Dose Expansion: Development Cohorts | Experimental | Drug: VLS-1488Subjects with other tumor types will be enrolled at a single dose level of interest. These Development Cohorts will be utilized to examine the preliminary efficacy of VLS-1488 in various tumor types. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All Parts: Age ≥ 18 years, ECOG Performance Status ≤ 1, at least 1 site of measurable disease evaluable by CT scan or MRI per RECIST 1.1, able to take oral medication without alteration
- Dose Escalation: No available therapeutic options to provide clinically meaningful benefits in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non -Small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction, Bladder (transitional cell), Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), Ovarian Carcinosarcoma, CN-high Endometrial/Uterine
- Dose Expansion: Must have been previously treated with several lines of standard of care treatment specified in the protocol in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non-Small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), CN-high Endometrial/Uterine
Key exclusion criteria (7 listed)
- MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype
- Previously received KIF18A inhibitor
- Current CNS metastases or leptomeningeal disease
- Cardiac parameters: MI or stroke ≤ 1 year, unstable angina/PE/DVT/CABG ≤ 6 months, NYHA Class ≥ II, LVEF < 50%
- Inability to comply with concomitant medication restrictions with respect to strong inhibitors and inducers of CYP3A, and clinical inhibitors of MDR1 (P-gp) and BCRP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VLS-1488VLS-1488 tablets will be given orally. | Drug | Dose Escalation: Backfill Cohorts, Dose Escalation: Dose Escalation Cohorts, Dose Expansion: Development Cohorts, Dose Expansion: Exploration Cohorts |
Primary outcome
Dose Escalation: Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects
Time frame: Up to 12 months
Dose Escalation: Determination of the MTD of VLS-1488
Time frame: Up to 12 months
Dose Escalation: Frequency of Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Time frame: Up to 12 months
Dose Escalation: Frequency of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0
Time frame: Up to 12 months
Dose Escalation: Frequency of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0
Time frame: Up to 12 months
Dose Escalation: Frequency of Dose Interruptions and Permanent Treatment Discontinuations
Time frame: Up to 12 months
Dose Expansion: Frequency of Trigger Events (TEs)
Time frame: Up to 18 months
Dose Expansion: Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Up to 18 months
19 secondary outcomes
Dose Escalation: ORR as assessed by RECIST version 1.1
Time frame: Up to 12 months
Dose Expansion: Frequency of SAEs graded according to NCI-CTCAE version 5.0
Time frame: Up to 18 months
Dose Expansion: Frequency of Treatment-related AEs graded according to NCI-CTCAE version 5.0
Time frame: Up to 18 months
Dose Expansion: Frequency of TEAEs graded according to NCI-CTCAE version 5.0
Time frame: Up to 18 months
Dose Expansion: Frequency of Dose Interruptions and Permanent Treatment Discontinuations
Time frame: Up to 18 months
Dose Expansion: Area Under the Plasma Concentration-Time Curve (AUC) of Midazolam and its metabolite 1'-hydroxymidazolam
Time frame: Up to 18 months
Dose Expansion: Maximum Plasma Concentration (Cmax) of Midazolam and its metabolite 1'-hydroxymidazolam
Time frame: Up to 18 months
Dose Expansion: Evaluation of CA-125 response by Gynecologic Cancer InterGroup (GCIG) criteria (High Grade Serous Ovarian Cancer only)
Time frame: Up to 18 months
Dose Escalation & Dose Expansion: Duration of Response (DOR) as assessed by RECIST version 1.1
Time frame: Up to 32 months
Dose Escalation & Dose Expansion: Disease Control Rate (DCR) as assessed by RECIST version 1.1
Time frame: Up to 32 months
Dose Escalation & Dose Expansion: Progression Free Survival (PFS) as assessed by RECIST version 1.1
Time frame: Up to 32 months
Dose Escalation & Dose Expansion: Cmax of VLS-1488
Time frame: Up to 32 months
Dose Escalation & Dose Expansion: AUC of VLS-1488
Time frame: Up to 32 months
Dose Escalation & Dose Expansion: Trough Concentration (Ctrough) of VLS-1488
Time frame: Up to 32 months
Dose Escalation & Dose Expansion: Time to Maximum Plasma Concentration (Tmax) of VLS-1488
Time frame: Up to 32 months
Dose Escalation & Dose Expansion: Ratio of Total Cholesterol to 4β-hydroxycholesterol in plasma
Time frame: Up to 32 months
Dose Escalation & Dose Expansion: Increase in the number of Phospho-Histone 3 positive tumor cells
Time frame: Up to 32 months
Dose Escalation & Dose Expansion: Frequency of Micronucleated Reticulocytes in blood
Time frame: Up to 32 months
Dose Escalation & Dose Expansion: Increase in Micronuclei in Circulating Tumor Cells
Time frame: Up to 32 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VLS-1488 in people with Advanced Solid Tumor and High Grade Serous Adenocarcinoma of Ovary, run by Volastra Therapeutics, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Volastra Therapeutics, Inc. ((646) 344-1248, clinicaltrials@volastratx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation: Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects (time frame: Up to 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.